Biodel Announces Commercial Supply Agreement With BD for Liquid Glucagon Rescue Device

Biodel Announces Commercial Supply Agreement With BD for Liquid Glucagon
Rescue Device

DANBURY, Conn., Dec. 17, 2013 (GLOBE NEWSWIRE) -- Biodel Inc. (Nasdaq:BIOD)
today announced a long-term supply agreement with BD (Becton, Dickinson and
Company), a leading global medical technology company, for worldwide exclusive
rights to the novel and proprietary BD Uniject SCF™ Disposable Auto-Disable
Injection System for the delivery of liquid glucagon to treat severe
hypoglycemia. Financial terms of the agreement have not been disclosed.

The BD Uniject SCF™ Disposable Auto-Disable Injection System is a small,
ultra-portable, all-in-one prefilled drug delivery system for intramuscular
and subcutaneous injections. Low unit costs allow Biodel to develop liquid
glucagon filled multipacks that enable users to remove a single device from
refrigerated storage every four months to be carried as a go-anywhere,
ultra-portable defense against the threat of severe hypoglycemia. The
multipack approach lowers the duration of room temperature stability required
for a convenient, portable rescue product and allows users who suffer frequent
hypoglycemic events to avoid the need to refill a prescription immediately
after using one of the devices. The ultra-portability and simplicity of the BD
Uniject SCF™ Disposable Auto-Disable Injection System may be particularly
compelling to active people with diabetes and parents of children with
diabetes. [A rendering of the device is available on Biodel's website at
www.biodel.com/uniject.]

Dr. Errol De Souza, Biodel's president and chief executive officer, stated:
"We are pleased to achieve another important milestone in our endeavor to
redefine the glucose rescue treatment standard. Adding the BD Uniject SCF™
Disposable Auto-Disable Injection System to our existing pipeline of adult and
pediatric auto-reconstitution devices will enable us to offer a portfolio of
devices to address and expand the underserved glucagon rescue treatment market
by replacing antiquated, difficult, and cumbersome multi-part kits with
simple, convenient, portable therapies that are close at hand when most
urgently needed."

Biodel will develop the BD Uniject SCF™ Disposable Auto-Disable Injection
System as a follow-on product to complement its auto-reconstitution devices,
for which an NDA submission is anticipated in 2015. Biodel's
auto-reconstitution devices are designed to offer two-year stability for
emergency glucagon administration with little to no training. The
auto-reconstitution devices automatically reconstitute lyophilized glucagon
and feature automatic needle retraction upon full dose delivery, minimizing
dosing errors and the risk of needle stick injuries. These features should
make the auto-reconstitution devices compelling products for institutions,
emergency responders, and many diabetes patients.

Biodel's portfolio of rescue devices should expand the overall glucagon rescue
market to a greater degree than a single product offering. Biodel is also
developing a pumpable liquid glucagon formulation for future use in an
artificial pancreas system.

About BD Uniject SCF™ Disposable Auto-Disable Injection System

The BD Uniject SCF™ Disposable Auto-Disable Injection System was developed in
the early 1980s with support from the U.S. Agency for International
Development to address the need for a low-cost vaccine delivery platform in
developing countries. The design uses a plastic blister filled with the
appropriate dose of medication for one injection. The device should require
little training and will be packaged and labeled in a manner so that a
non-healthcare professional caregiver can easily administer a dose in an
emergency. The user simply pushes in the cap to activate it, inserts the
needle, and squeezes the blister. The BD Uniject SCF™ Disposable Auto-Disable
Injection System has been used in numerous vaccination campaigns in Africa,
Asia, and Indonesia.

About Severe Hypoglycemia & Glucagon Rescue

Diabetes patients using insulin commonly experience varying degrees of low
blood glucose concentration known as hypoglycemia. Mild to moderate
hypoglycemia symptoms such as headache, weakness, or dizziness are generally
treated with orally administered carbohydrates, such as orange juice or
glucose tablets. Severe hypoglycemia, however, often results in a loss of
consciousness or seizures, which typically renders the oral administration of
carbohydrates unsafe and requires another person's assistance. In such
emergency cases, an injection of glucagon can help rapidly raise the patient's
blood glucose concentration. The longer a patient is unconscious due to severe
hypoglycemia, the greater the chance of brain damage or death. It is estimated
that there are over 200,000 hospitalizations per year due to severe
hypoglycemia.

Glucagon is a hormone secreted by the pancreas which opposes the action of
insulin by promoting the breakdown of glycogen into glucose in the liver,
thereby raising the levels of blood glucose. Glucagon is inherently unstable
in a liquid solution and therefore is currently only available as a rescue kit
consisting of a vial containing a dry powder of glucagon and a syringe
containing a liquid solution. To administer glucagon with this kit, the liquid
solution must first be injected into the vial with the dry powder and mixed.
After the glucagon powder has dissolved, it is then drawn back into the
syringe and injected into the patient. In order to properly administer the
glucagon, a caregiver must be trained to follow this multi-step process in a
situation typically made challenging by the patient's condition.

It is widely understood by patients, physicians and Diabetes Educators that
the complexity of the currently available rescue kits and the training
required for proper administration of glucagon using those kits has resulted
in the underuse of glucagon as a rescue treatment for diabetes patients
experiencing severe hypoglycemia. It is estimated that less than 10% of
high-risk patients currently have an unexpired glucagon kit. Given this low
level of market penetration, the current $125 million U.S. market could expand
significantly upon the introduction of an easy-to-use presentation. The BD
Uniject SCF™ Disposable Auto-Disable Injection System requires three simple,
intuitive steps as compared to seven or more steps for the currently available
rescue kits.

About Biodel Inc.

Biodel Inc. is a specialty biopharmaceutical company focused on the
development and commercialization of innovative treatments for diabetes that
may be safer, more effective and more convenient for patients. Biodel's
product candidates are developed by applying proprietary technologies to
existing drugs in order to improve their therapeutic profiles. More
information about Biodel is available at www.biodel.com.

Safe-Harbor Statement

This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. Such forward-looking
statements include statements about future activities related to the clinical
development plans for the company's drug candidates, including the potential
timing, design and outcomes of clinical trials; and the company's ability to
develop and commercialize product candidates. Forward-looking statements
represent our management's judgment regarding future events. All statements,
other than statements of historical facts, including statements regarding our
strategy, future operations, future clinical trial results, future financial
position, future revenues, projected costs, prospects, plans and objectives of
management are forward-looking statements. The words "anticipates,"
"believes," "could," "estimates," "expects," "intends," "may," "plans,"
"potential," "predicts," "projects," "should," "will," "would" and similar
expressions are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words. The company's
forward-looking statements are subject to a number of known and unknown risks
and uncertainties that could cause actual results, performance or achievements
to differ materially from those described or implied in the forward-looking
statements, including, but not limited to, the success of our product
candidates, particularly our proprietary formulations of injectable insulin
that are designed to be absorbed more rapidly than the "rapid-acting" mealtime
insulin analogs presently used to treat patients with type 1 and type 2
diabetes and our glucagon presentation that is intended to treat patients
experiencing severe hypoglycemia; our ability to conduct pivotal clinical
trials, other tests or analyses required by the U.S. Food and Drug
Administration, or FDA, to secure approval to commercialize a proprietary
formulation of injectable insulin or a stable glucagon presentation; the
success of our formulation development work with insulin analog-based
formulations of a proprietary injectable insulin and a stable glucagon
presentation; our ability to secure approval from the FDA for our product
candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic
Act; the progress, timing or success of our research, development and clinical
programs, including any resulting data analyses; our ability to develop and
commercialize a proprietary formulation of injectable insulin that may be
associated with less injection site discomfort than Linjeta™ (formerly
referred to as VIAject® ), which is the subject of a complete response letter
we received from the FDA; our ability to enter into collaboration arrangements
for the commercialization of our product candidates and the success or failure
of any such collaborations into which we enter, or our ability to
commercialize our product candidates ourselves; our ability to protect our
intellectual property and operate our business without infringing upon the
intellectual property rights of others; the degree of clinical utility of our
product candidates; the ability of our major suppliers to produce our products
in our final dosage form; our commercialization, marketing and manufacturing
capabilities and strategies; our ability to accurately estimate anticipated
operating losses, future revenues, capital requirements and our needs for
additional financing; and other factors identified in our most recent report
on Form 10-Q for the quarter ended June 30, 2013. The company disclaims any
obligation to update any forward-looking statements as a result of events
occurring after the date of this press release.

BIOD-G

CONTACT: John Graziano, +1 (646) 378 2942
 
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